FDA+ channel feed – Endpoints News

FDA+ channel feed

AstraZeneca lands FDA approval for AKT inhibitor in biomarker-defined breast cancer subset

Last year

Slew of House Democrats urge FDA, HHS to preserve access to misoprostol, methotrexate

Last year

'Well underway': FDA calls for faster confirmatory trials for accelerated approvals

Last year

FDA's Janet Woodcock to retire in early 2024

Last year

FDA hands down approval for Bristol Myers' lung cancer drug from Turning Point buyout

Last year

In a world first, Vertex, CRISPR win UK approval for CRISPR-edited therapy to treat sickle cell disease, beta-thalassemia

Last year

CorMedix wins US approval via rarely-used pathway for drug to reduce bloodstream infections

Last year

Can post-market evidence generation be streamlined? FDA-commissioned report proposes solutions

Last year

FDA raises concerns over efficacy of Merck's potential chronic cough drug ahead of adcomm

Last year

Amazon lands FDA warning letter over distribution of seven unapproved eye drops

Last year

New NIH chief stresses focus on obesity, clinical trial challenges

Last year

FDA touts new authority as ODAC hosts adcomm to review delayed confirmatory trials for accelerated approvals

Last year

Japan considers adjusting clinical trial requirements to remove the need for local studies — report

Last year

FDA explains why it denied about 60% of non-oncology breakthrough therapy requests from 2017 to 2019

Last year

EMA committee recommends approvals for Lilly's weight loss drug, Mirati's KRAS inhibitor and more

Last year

House Republicans threaten to subpoena FDA over Covid research documents

Last year

Valneva receives first chikungunya vaccine approval after two month delay to FDA review

Last year

FDA approves Takeda's new enzyme replacement therapy for rare blood clotting disorder

Last year

ADF asks SCOTUS not to take up mifepristone case as Danco, DOJ say arguments don't hold up

Last year

How Boehringer Ingelheim and Pfizer battled over the exclusivity of the first Humira interchangeable

Last year

Takeda scores FDA approval for $400M colorectal cancer therapy

Last year

FDA watchdog admonishes Evofem for marketing brochure for its contraceptive Phexxi

Last year

FDA approves an unbranded version of megablockbuster Humira, but AbbVie says it won't 'currently' launch

Last year

Senate Finance Committee unanimously advances PBM, Medicare Part D reforms

Last year

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